Data / Medical devices / Germany / Sensatronic GMBH
Sensatronic GMBH: FDA-registered device maker in Wismar Mecklenburg-Western Pomerania, Germany, 1 510(k) clearance
Sensatronic GMBH is registered with the FDA (registration 3010370454) in Wismar Mecklenburg-Western Pomerania, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010370454
- Address
- Am Ring 9, Wismar Mecklenburg-Western Pomerania, Germany, 23970
- Owner or operator
- Sensatronic GmbH (10043350)
- Roles
- Manufacturer
- First device listed
- February 7, 2013
- Registered through
- 2026
- Brand names listed
- Sensatronic Reusable Temperature Probes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Gas Flow | BXP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2021 | K203643 | Sensatronic Reusable Temperature Probes | FLL | Substantially Equivalent | Sensatronic GmbH | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.